Cobalamin Status in Young Children With Gastrointestinal Symptoms or Feeding Problems

What Was Tested

The trial (not phased) is built around Cyanocobalamin (Vitamin B12).

During fetal life and infancy, an adequate cobalamin status is important for normal growth and central nervous system development.

It had two arms (groups): 1 (active comparator) and 2 (sham comparator).

The controls receive an intramuscular "injection", however, it is only an introduction of the needle into the muscle, but no injections are given. The syringe is covered so it is impossible to see whether or not it contains any substance.

The registry classes the interventions as dietary supplement.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to people of any sex aged up to 8 months.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Children below 8 months of age. Clinical diagnosis or symptoms: feeding problems and/or gastrointestinal symptoms.

The full record lists 2 inclusion and 1 exclusion criteria; among the exclusions: children with syndromic disease.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.

Those kept unaware of assignments: care provider, investigator and outcomes assessor.

It started in 2008-04 with completion listed for 2010-08.

It ran at 1 site in Norway.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, growth parameters, symptom and neurological evaluation (time frame: Reevalutation after 4 weeks).

It also tracked 1 secondary outcome, for example Maternal evaluation of changes in infant behaviour and symptoms.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 100 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.